Operations Quality Manager

Do you want to improve the life of people with a hearing disability? Are you a Quality Manager or Quality Engineer with passion for Production and Process control within the medical device area? Then we might have an exciting position for you as Operations Quality Manager at Oticon Medical BAHS in Gothenburg.

At Oticon Medical BAHS we develop and market bone anchored hearing systems including active and non-active implants, sound processors, software and various accessories. We are now looking to add a great new member to our Operations team were we, among other key tasks, are responsible for purchasing, production and logistics in collaboration with external partners.

As Operations Quality Manager, reporting to Head of Operations, you will be responsible for production and process control of all our outsourced production and distribution processes. You will be involved in setting up and maintaining production processes in collaboration with our suppliers as part of product development projects, supplier change projects and projects related to distribution and return flows. You ensure production quality of all our medical devices by securing that activities are well defined, planned, documented, and executed according to Medical Device standards and regulations, all in close collaboration with internal and external partners.

Your responsibilities
You will ensure production and process quality for all Oticon Medical BAHS products through outsourced partners.
Create input to production and process requirement specifications including traceability and handling procedures.
Develop and maintain specifications, instructions and procedures for production quality monitoring and release of products.
Develop process validation master plans, ensure establishment, and maintain process quality documentation.
Process owner of the sterilization process – E-beam & ETO
Drive CAPAs and follow up of corrective actions related to production and process performance.
Represent production and process control as subject matter expert during external audits.
Drive the supplier audit plan, execute audits as lead auditor, document, and follow-up.
Prepare yearly supplier evaluation reports including performance KPI´s.
Provide process performance data to management QMS review



Your experience and qualifications
You come along with a degree in Engineering and a minimum of 5 years of work experience, preferably related to production quality of high-class medical devices. You have through knowledge of MDSAP, ISO 13485 and GMP requirements. Experience from sterilization processes validation both E-beam & ETO is highly meriting.
You are stimulated by building relationships and implementing improvements and new processes as well as working in cross functional teams with your colleagues.
Your professional style is characterized by your ability to work structured and focused in a technical and professional manner.
Besides that, we expect that you are pragmatic and strive for efficiency in all that you do.
· You think and act holistically and like to take responsibility
· You are skilled in creating and maintaining good relations to all parts of the organization
· You know how to benefit from multi-site and multi-cultural development teams
Besides the above mentioned, we prefer flexible candidates who can travel up to 20 days per year.

We dare to make a difference
Together with skilled colleagues, you are part of a dynamic environment based on trust and openness, and you will experience a strong will to win. We are a growing international company where everybody supports the business by contributing to the customers’ experience of our products as the most attractive to work with. You will be working in a bright and open workplace, where a flexible working environment, knowledge sharing, and professional respect makes it both challenging and meaningful to go to work.
Would you like to know more?
Then send your application and CV through our online recruitment system latest on June 11, 2021. Please do not send us your application via e-mail.
If you would like to know more about the position, you are welcome to contact Head of Operations Niklas Aulin on niau@oticonmedical.com.
We are looking forward to hearing from you.

Oticon Medical is part of Demant group with more than 14.500 employees across the world. Oticon Medical is the fastest growing manufacturer of bone anchored and cochlear implant hearing systems for children and adults. At Oticon Medical we combine more than a century of experience in audiology and sound processing from Oticon with decades of pioneering experience in hearing implant technology. Our connection to Oticon gives us unique access to knowledge, resources and technology that we use for developing innovative and life-changing implantable hearing